The Organ Systems Branch of the Office of Centers, Training,
and Resources, Office of the Director, National Cancer Institute, invites
grant applications for Specialized Programs of Research Excellence (SPOREs)
in organ-specific cancers. Applicant institutions are to demonstrate their
ability to conduct translational research in the prevention, etiology, screening,
diagnosis, and treatment of leukemias, lymphomas, myelomas, and/or cancers
of the brain, breast, gastrointestinal (GI) system, genitourinary (GU) system,
gynecologic (GYN) system, head & neck, lung, ovary, pancreas, prostate,
and/or skin. Translational research, as defined by the Program, uses knowledge
of human biology to develop and test the feasibility of cancer-relevant
interventions in humans and/or determines the biological basis for observations
made in individuals with cancer or in populations at risk for cancer.

The support for SPOREs is through the NIH specialized
center grant (P50) mechanism.

Required components of a SPORE (P50) grant application
and grant include a minimum of four translational research projects, one
or more cores, and a developmental research and career development program.
A required core in a SPORE is a human cancer tissue core for the particular
organ site that will benefit translational research.

SPOREs foster extended collaborations in critical areas
of research among laboratory and clinical or applied scientists. Every SPORE
is expected to have a robust research base in the respective cancer, good
access to patient populations, and substantial commitment from their institution.
Inter-SPORE collaborations and collaborations between SPOREs and other NIH
programs are strongly encouraged. Each SPORE and the "network"
of SPOREs are expected to conduct research that will have the most immediate
impact possible on reducing incidence and mortality of human cancer.

Eligible organizations include: for-profit or non-profit
domestic organizations; public or private institutions, such as universities,
colleges, hospitals, and laboratories; units of State government(s); units
of local government(s); eligible agencies of the Federal government; and
faith-based or community-based organizations; Indian/Native American Tribal Government (Federally Recognized),
Indian/Native American Tribal Government (Other than Federally Recognized),
and Indian/Native American Tribally Designated Organizations. Foreign institutions and organizations are not eligible to apply for P50
SPORE grants.

Any individual with the skills, knowledge, and resources
necessary to carry out the proposed research is invited to work with their
institution to develop an application for support.

A SPORE maintains state-of-the-art research that will contribute
to improved screening, detection, diagnosis, treatment, and prevention of
an organ-specific cancer (or related group of cancers). SPOREs are expected
not only to conduct a wide spectrum of research activities, but should also
contribute significantly to the development of specialized research cores,
improved research model systems, and collaborative research projects with
other institutions. The research supported through this program must be translational
in nature. Translational research involves the use of knowledge of human biology
to develop and test the feasibility of cancer-relevant interventions in humans
and/or to determine the biological basis for observations made in individuals
with cancer or in populations at risk for cancer. Inherently, this process
involves interdependence between investigators conducting basic and applied
research. It should be noted that clinical and/or epidemiological research
that does not include a laboratory component or capitalize upon a biological
discovery relevant to human cancer is not considered translational for the
purposes of this program.

A SPORE is supported through the specialized center (P50)
grant mechanism. Applicants are solely responsible for planning, directing,
and executing the proposed project. This mechanism provides funding for a
broad range of research and developmental activities, from basic to human
intervention studies. These grants are intended to promote multidisciplinary
research focused upon a specific cancer (or related cancer) site(s). SPORE
grants differ from traditional Program Project (P01) grants in that they also
provide support for pilot research projects and a career development program,
as well as enable investigators more flexibility to modify their research
activities when new opportunities arise.

This funding opportunity uses just-in-time concepts. It
also uses the non-modular budget format described in the PHS 398 application
instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and
the "Entire Proposed Period of Support" is to be submitted with
the application.

2. Funds Available

NCI policy for SPORE grants establishes the following limits
to the requested budgets: new or competing renewal P50 SPORE applications
may each request a maximum annual total cost of $2.5 million. The facilities
and administrative (F&A) costs related to subcontracts to other institutions
or organizations are included in the total cost cap of $2.5 million,. Applications
can exceed this caps in subsequent years as a result of standard cost-of-living
increases or special supplements approved by NCI.

A SPORE grant application may be submitted for up to 5
years of funding.

Because the nature and scope of the proposed research will
vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the
NCI provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications.

Facilities and administrative (F&A) costs requested
by consortium participants are not included in the direct cost limitation,
see NOT-OD-05-004.

Section
III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization
has any of the following characteristics:

For-profit organizations;

Non-profit organizations;

Public or private institutions, such as universities,
colleges, hospitals, and laboratories;

Units of State Government(s);

Units of local Government(s);

Eligible agencies of the Federal Government;

Domestic institutions (only); and

Faith-based or community-based organizations;

Indian/Native American Tribal Government (Federally Recognized);

Indian/Native American Tribal Government (Other than Federally Recognized);
and

Indian/Native American Tribally Designated Organizations.

Eligible institutions may include Foreign components as
full research projects, or cores, or as part of a research project or core,
but Foreign institutions and organizations are not eligible to submit SPORE
applications. SPOREs may also use developmental funds to establish collaborative
research efforts with foreign entities. Consortia agreements with Foreign
institutions must include provisions that ensure adequate representation of
women, minorities, and children in all research components that involve clinical
trials or any other type of human intervention and must be in compliance with
NIH policies.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources
necessary to carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applications must be prepared using the most current PHS
398 research grant application instructions and forms. Applications must have
a D&B Data Universal Numbering System (DUNS) number as the universal identifier
when applying for Federal grants or cooperative agreements. The D&B number
can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS
398 form.

The title and number of this funding opportunity must be
typed on line 2 of the face page of the application form and the YES box must
be checked.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows NCI staff to estimate the potential review workload
and plan the review.

The letter of intent is to be sent by the date listed at
the beginning of this document.

The letter of intent should be sent to the NCI Program
Directors for the specified organ sites at the following address:

Applications must be prepared using the PHS 398 research
grant application instructions and forms as described above. Submit a signed,
typewritten original of the application, including the checklist, and three
signed photocopies in one package to:

Applications must be received on or before the application
receipt/submission date(s) described above (Section
IV.3.A.). If an application is received after that date, it will be
returned to the applicant without review.

Upon receipt applications will be evaluated for completeness
by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to
this funding opportunity that is essentially the same as one currently pending
initial review unless the applicant withdraws the pending application. The
NIH will not accept any application that is essentially the same as one already
reviewed. This rule does not preclude the submission of a substantial revision
of an application already reviewed, but such application must include an Introduction
addressing the previous critique.

All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own
risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new or competing continuation award if such costs: are necessary
to conduct the project, and would be allowable under the grant, if awarded,
without NIH prior approval. If specific expenditures would otherwise require
prior approval, the grantee must obtain NIH approval before incurring the
cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or
competing continuation award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is
made for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the approved
time frame or in any way adversely affect the conduct of the project. See
the NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

SPORE applications must also have the following elements:

(1) Institutional Support. A statement must be provided
that addresses how how the institutional commitment will be established and
sustained, how the institution will maintain accountability for promoting
scientific excellence, and how the SPORE research effort will be given a high
priority within the institution (relative to other research efforts). The
institutional commitment may be in the form of support for recruitment of
scientific talent, provision of discretionary resources to the SPORE Director,
assignment of specialized research space, cost sharing of resources, and/or
other ways proposed by the applicant institution. The primary institution
is strongly encouraged to demonstrate its commitment to SPORE by providing
financial support to the Developmental Research and Career Development Programs
on an awarded SPORE, as well as other programmatic needs identified as high
priority on the original application. Letters from a high-level institution
official(s) (e.g., Dean of the School of Medicine, President, and Vice President
for Research) and the Cancer Center Director should be attached confirming
this commitment. In the case of a SPORE that involves a consortium arrangement
between two or more institutions, the institution that submits the P50 application
must receive a formal written agreement(s) from the other participant organization(s).
This agreement should clearly delineate the institutional commitment of the
participating organization(s) (in the ways outlined above) to the Program.

(2) Access to cancer patient population. Each SPORE
must document access to a substantial patient population in the cancer-site
focus of the application and provide reasonable assurance that the patients
and human specimens needed for translational research are readily available.
If the appropriate patient population is not available at the applicant institution,
a consortium agreement may be established with a different institution to
provide adequate access to clinical specimens (e.g., tissues, blood, and urine)
and/or patients at another site.

(3) Minimum Research Base. Significant role of a
minimum of four independent investigators who are successful in obtaining
peer-reviewed research support directly related to the cancer being investigated.
To qualify, respective individuals must currently serve as PIs (or project
leaders) on peer-reviewed research grants (e.g., R01, R21, P01, U01,
U10, American Cancer Society [ACS], U.S. Department of Defense [DOD], or equivalent)
or serve as overall chairpersons or site chairpersons on active NCI cooperative
group clinical trial(s) or committees directly related to the cancer(s) being
investigated by the proposed SPORE. PIs supported by the NCI through K05,
K22, K24, or K25 career development grants can also be included in this research
base requirement if the career award is directly relevant to the cancer being
investigated on the SPORE. an investigator who is a PI on multiple qualified
grants or clinical trials only counts once towards the research base and,
in order to qualify, the investigator must be the PI (not co-investigator)
on the highlighted activity. The qualifying investigators also must have
a significant role on the SPORE (i.e., greater than or equal to a 5 percent
contributed effort as a project co-leader, co-investigator, or core director);
they cannot just serve as mentors within the proposed Career Development Program
or be the project leader of a proposed Developmental Research project. The
funded activities of the investigators who fulfill the requirements of a minimal
research base should be included in the Program Description part of the SPORE
application as discussed in Section II below.

(4) Research Projects. A minimum of four research
projects, representing a balance and diversity of translational approaches.

Each proposed research project must meet the definition
of translational research as described in Section I.B above. Investigators
who are not certain about whether their project fits this definition are
advised to consult with NCI program staff.

Each proposed research project must be designed to test the relevance and/or
potential importance of the research to human cancer within the 5-year term
of the grant (e.g., validation of a new screening mechanism or diagnostic
test, early phase therapeutic trial, analysis of human tissues such as tumor
or bloodsamples).Basic research projects, such asthoseemploying animal models or cell lines, qualify as translational only if
a human application is included in the specific aims of the research. A project(s)
proposed in a competitive renewal application may focus solely upon the human
application or laboratory effort if it marks the final stage of an ongoing
translational SPORE study. Applicants are encouraged to contact the Organ
Systems Branch (see INQUIRIES above) if they have any questions concerning
this essential requirement.

Each proposed research project must be led by project co-leaders, one in
basic biological sciences and one in applied sciences, who commit adequate
percent efforts and who use their combined conceptual and experimental skills
in designing and implementing the project. It should be evident from this
collaboration that translational research objectives will be accelerated such
that it will be possible to test the relevance of the underlying hypotheses
or to generate new hypotheses relevant to human disease. It is not necessary
that the co-leaders commit equal effort to the project. There are NO
exceptions to this requirement.

For most organ sites, at least ONE research project must focus on
early detection, screening, prevention (primary or secondary), and/or population
science research. See Table 1 below for a list of the organ sites supported
by the SPORE program and which of these sites require a project focused on
early detection, screening, prevention, or population science. If such a
project is required, then at least one scored project in this category will
be required for award (see REVIEW CONSIDERATIONS, Section II.G.1.) and must
be maintained throughout the entire term of the award.

Only early (Phase I and Phase II) clinical trials may be supported by the
SPORE mechanism. A plan for a clinical trial must include provisions for
rigorous data management, quality assurance, and safety monitoring.

(5) Shared Cores. Shared cores designed to support
the proposed translational objectives of the SPORE (including the required
human cancer tissue/specimen core for the particular organ site).

Specimen Core (Required). Each SPORE must have
a dedicated core for collecting and distributing human cancer site-specific
and/or related specimens. Specimens include fixed tissue, frozen tissue,
paraffin blocks, slides, preserved cells, serum, plasma, urine, sputum samples,
and other body fluids. The specimen core should also include the essential
pathological, clinical, and family history information needed for conducting
a wide range of translational research activities. Appropriate informatics
capability for tracking, as well as linkage to clinical and follow-up data
sets, should be demonstrated.

Other Cores (Optional). Additional shared cores (e.g., administrative,
clinical, biostatistical, animal, etc.) may also be proposed that are supportive
of one or more of the research projects of the SPORE. These cores should
provide essential services to at least one SPORE project and may also
include other analytical or non-hypothesis driven research activities designed
to enhance a service.

(6) A developmental research program. Every SPORE
must allocate a significant effort (with a minimum required allocated budget
of $50,000 in direct costs per year) to support pilot projects that take maximum
advantage of new research opportunities. Such projects may be collaborative
among scientists within one or more SPOREs, or with scientists outside the
SPORE environment. In the application, the applicant SPORE application should
propose an institutional review process for funding pilot projects that generate
feasibility data and have the most promising translational research potential.

(7) A career development program (with a minimum
required allocated budget of $50,000 in direct costs per year). The SPORE
must demonstrate a consistent and significant commitment to a career development
program (CDP) in translational cancer research. Funds from this program may
be used to support advanced post-doctoral or clinical fellows (who will be
independent investigators within the next year), junior faculty, or established
investigators who wish to develop or refocus their careers on translational
research. SPORE career development programs are not intended for predoctoral
candidates or junior level post-doctoral and clinical fellows. Investigators
supported by NCI career development awards (K series) may also be eligible
for support through this program.

(8) Collaborative Arrangements (if applicable).
Although an application can only be submitted by a single institution, subcontracted
collaborative arrangements with scientists from other institutions may be
included if these arrangements are clearly delineated and officially confirmed
by signed statements from the responsible official at each institution. This
circumstance, however, does not preclude the need for a full institutional
commitment from the applicant organization.

(9) Budget documentation. Applications must contain
documentation regarding the appropriateness of requested budgets to conduct
proposed services. All proposed cores must include a budgetary request from
SPORE funds. For example, the appropriateness of the budget with regard to
the conduct of activities related to the banking, analysis, and distribution
of specimens must be discussed in the application. For both the developmental
research program and for the career development program, the appropriateness
of the budget (whether derived entirely from the SPORE or a combination of
sources) relative to the needs and demonstrated capabilities of the SPORE
and to the proposed plans for sustaining a significant effort in career development,
respectively, must be documented. SPORE application budget must also project
the required attendance of SPORE lead investigators (i.e., principal investigators,
project leaders, core directors, and other key personnel) at SPORE workshops
and related meetings.

(10) Intellectual Property Rights (if applicable). An
intellectual property management plan (IPMP) must be included in the application
which discusses the plans for evaluation, protection, and commercialization
of solely or jointly owned SPORE inventions, including any patenting and licensing
strategies. This plan should be comprehensive for all proposed SPORE projects
and be included in the Program Description as specified in Section II. The
IPMP will not be evaluated during the peer review of applications, but it
is an administrative requirement that will be evaluated carefully by NCI program
staff.

The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning
to share the data. Applicants who are planning to share data may wish to describe
briefly the expected schedule for data sharing, the format of the final dataset,
the documentation to be provided, whether or not any analytic tools also will
be provided, whether or not a data-sharing agreement will be required and,
if so, a brief description of such an agreement (including the criteria for
deciding who can receive the data and whether or not any conditions will be
placed on their use), and the mode of data sharing (e.g., under their own
auspices by mailing a disk or posting data on their institutional or personal
website, through a data archive or enclave). Investigators choosing to share
under their own auspices may wish to enter into a data-sharing agreement.
References to data sharing may also be appropriate in other sections of the
application.

Applicants requesting more than $500,000 in direct costs
in any year of the proposed research must include a plan for sharing research
data in their application. The funding organization will be responsible for
monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale
for not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score.

The adequacy of the resources sharing plan and any related
data sharing plans will be considered by Program staff of the funding organization
when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section
VI.3. Reporting.

Appendix materials

The following materials may be included in the Appendix:

Publications in press: Include only a
publication list with a link to the publicly available on-line journal article
or the NIH PubMed Central (PMC) submission identification number. Do not
include the entire article.

Manuscripts accepted for publication but not yet published: The entire
article may be submitted electronically as a PDF attachment.

Manuscripts published but a publicly available online journal link is
not available: The entire article may be submitted electronically
as a PDF attachment.

Applicants are cautioned not to use the Appendix to circumvent
the page limitations of the Research Plan. An application that does not observe
the relevant policies and procedures may be delayed in the review process.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the PA
will be evaluated for scientific and technical merit by an appropriate peer
review group convened by the Division of Extramural Activities of the NCI
in accordance with the review criteria stated below.

As part of the initial merit review, all applications:

Undergo a selection process in which only those applications
deemed to have the highest scientific merit will be discussed and assigned
a priority score;

Receive a written critique; and

Receive a second level of review by the National Cancer
Advisory Board.

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined
by peer review;

Availability of funds; and

Relevance to program priorities.

The goals of NIH-supported research are to advance our
understanding of biological systems, to improve the control of disease, and
to enhance health. In their written critiques, reviewers will be asked to
comment on each of the following criteria in order to judge the likelihood
that the proposed research will have a substantial impact on the pursuit of
these goals. Each of these criteria will be addressed and considered in assigning
the overall score, weighting them as appropriate for each application. Note
that an application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority score.
For example, an investigator may propose to carry out important work that
by its nature is not innovative but is essential to move a field forward.

a. Research Projects

Within the SPORE concept of translational research (see
definition in the Executive Summary and in Part II, Section
I.1. above), reviewers will evaluate each research project using the five
review criteria below and additional factors noted further below. Each criterion
will be considered by the reviewers in assigning the overall merit score of
the project, although a project does not need to be strong in all criteria
in order to be viewed as meritorious.

1. Significance.
Does this study address an important translational research goal or barrier?
Is it likely the study will be completed within the project period? If the
aims of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the impact of these studies on the concepts,
methods, technologies, treatments, services, or preventative interventions
that drive this field? If a project is ongoing, did it achieve its goals within
the previous funding period; is scientific progress adequate?

2. Approach.
Are the conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of
the project? Is there clear evidence of co-leadership between both a basic
biological and applied or clinical scientist in the conception, design, and
proposed implementation of the project? Do the project co-leaders acknowledge
potential problem areas and consider alternative tactics? If the project is
ongoing and has changed research direction, is there appropriate rationale
for the new approach?

3. Innovation.
Is the project original and innovative in the context of translational research?
For example: Does the project challenge existing paradigms or clinical practice;
address an innovative hypothesis or critical barrier to progress in the field?
Does the project develop or employ novel concepts, approaches, methodologies,
tools, or technologies for this organ site?

4. Investigators.
Are the investigators appropriately trained and well suited to carry out this
work? Is the work proposed appropriate to the experience level and time commitments
of the co-leaders and co-investigators on the project? Does the investigative
team bring complementary and integrated expertise to the project?

5. Environment.
Does the scientific environment in which the work will be done contribute
to the probability of success? Do the proposed studies benefit form unique
features of the scientific environment, or subject populations, or employ
useful collaborative arrangements? If applicable, is there evidence of effective
use of SPORE cores?

For competing renewal applications, adequate progress
should be demonstrated on projects that are ongoing. Any difficulties in achieving
the previously proposed specific aims should be addressed and the new research
goals should be logical extensions for the project. There should be clear
evidence that such a project reached its anticipated human application(s)
during the previous funding period and the continuation of the project will
lead to new translational findings. It should also be evident that the investigative
team, especially the project co-leaders, established a productive working
relationship during the past performance period and have published or submitted
manuscripts describing their previous findings.

b. Cores

1. Specimen core (this human cancer tissue/specimen
core for the particular organ site is a required component of a SPORE).

Does the proposed plan for this core adequately address
the development, annotation, and maintenance of a human cancer site-specific
specimen resource, including linkage of specimens with pre-analytical parameters
and pathological, clinical, and family history data that maximize their
potential use in translational research?

Does the proposed plan adequately address and prioritize
the distribution of specimens within and outside the SPORE? (For competing
renewal applications, there should be clear documentation of the use of
specimens by SPORE investigators within full and developmental projects,
as well as details, if applicable, about the distribution and use of SPORE
collected specimens outside of the SPORE and/or institution.)

If applicable, does the proposed plan adequately address
the performance of analyses on specimens (e.g., tissue microdissection,
immunochemistry) and/or develop new technologies and methodologies that
enhance or benefit activities of the SPORE? (For competing renewal applications,
there should be clear documentation that demonstrates these analyses were
critical to the success of certain projects and are worthy of continued
support, if requested.)

Is sufficient evidence of experienced personnel dedicated
to the activities of specimen collection, annotation, quality control, storage,
distribution, and analysis; as well as overseeing the collection of initial
and follow-up clinical information, data entry, and maintenance of database
and computer networks presented? (For competing renewal applications, the
performance and relative time commitments of these individuals should also
be evaluated based on the past accomplishments of the core).

Does the proposed plan give sufficient evidence that
the activities of the core are well integrated with those of the projects
and the investigators within the projects are working closely with those
of the core to meet project objectives?

Does the proposed plan adequately augment and/or complement
any existing specimen resource supported by a Cancer Center Support Grant
(CCSG; P30 grant mechanism) or other funding mechanism(s) to avoid duplication
and maximize productivity? Do investigators applying from institutions with
a CCSG and multiple SPORE grants address how their core will benefit from
already established infrastructure, databases, etc., that will enable this
proposed specimen core to be more cost effective and efficient?

Does the proposed plan adequately address if and how
the investigators will obtain written informed consent for all prospectively
collected tissues/specimens in a manner that will protect patient confidentiality?

2. Other Cores

Does the proposed plan for each other core adequately
indicate that it (will) effectively and efficiently support the research
of the SPORE in a manner that can not be supported through other available
(institutional or outside) resources?

Does the proposed plan demonstrate that the activities
of the core are essential to one or more SPORE projects? (For competing
renewal applications, demonstrated use of each core by SPORE projects during
the previous funding period is critical and should be evaluated.)

Does the proposed plan demonstrate that the activities
of the core are well integrated with those of the projects and the investigators
within the projects are working closely with those of the core to meet project
objectives?

If applicable, does the proposed plan demonstrate the
activities of the core related to the performance of specialized analyses
or development of technologies or methodologies that enhance and benefit
the projects?

When appropriate, does the proposed plan address how
the investigators will augment any existing shared resource supported by
an NCI Cancer Center Support Grant (P30 grant mechanism) of other funding
mechanism? (There should be adequate details within the core description
to assure there is no duplication of services with pre-existing cores at
the Cancer Center or institution.)

Does the proposed plan address the qualifications, past
performance (if applicable), and time commitments of the Core Director(s)?

c. Developmental Research Program (DRP)

1. Does the proposed plan for the DRP address attracting
new ideas and pilot studies within and outside of the SPORE institution? The
outreach capabilities of a SPORE are often demonstrated within this program.

2. Does the proposed plan address continuously reviewing
and funding a spectrum of pilot projects with translational research potential?
(For competing renewal applications, this program should also be evaluated
by the SPORE's ability to promote outstanding translational pilot projects
to full projects and/or demonstrate the successful competition of these projects
for outside funds.)

d. Career Development Program (CDP)

1. Does the proposed plan for the CDP describe how promising
candidates for independent careers (academic, industrial, governmental) in
translational cancer research will be selected? (For competing renewal applications,
current status and research activities of individuals who have been supported
by the career development program. This may include the promotion of outstanding
career development projects to full projects within the SPOREs and involve
the continuing support and integration of successful career development awardees
as project co-leaders or co-investigators.)

2. Does the proposed plan address how the investigators
will seek out and include qualified women and minorities for participation
in the proposed program?

e. Overall Program Organization, Interaction, and Capability

1. Leadership

Are the scientific qualifications and involvement of the
principal investigator as well as his/her scientific and administrative leadership
capabilities and time commitment presented and sufficient for the requirements
of the proposed SPORE?

2. Institutional Commitment

Is the institutional commitment for facilitating the research
objectives of the SPORE (e.g., special facilities, recruitments, discretionary
resources, such as dollars and space) documented and sufficient?

3. Integration within the SPORE and the Institution

Do the plans for integrating the activities of SPORE projects
with proposed cores, as well as integrating SPORE research and cores with
existing Cancer Center/institutional resources (e.g., use of clinical data
and safety management systems, biostatistical cores, etc.), give confidence
and sufficient evidence that such efforts are likely to be effective? (Note
that SPORE projects are not required to interact with each other.)

4. Cancer Patient Population

Is the access to patients and populations for conducting
current and projected therapeutic, prevention, detection, and control research
adequate to ensure likely success of the goals of the program? (For competing
renewal applications, documentation of accomplished translational goals, including
evidence of human subjects enrollment on clinical/population research studies
during the past funding period should be provided.)

5. Planning and Evaluation of Activities

Are the plan(s) and/or track record(s) to evaluate the
translational research productivity of existing projects and cores; discontinue
activities of low productivity; initiate new activities in response to important
translational research opportunities; establish collaborations; and utilize
the advice of internal and external advisors presented and sufficient for
the requirements of the proposed SPORE?

6. Collaborations

Is there evidence of tangible interactions with other SPOREs
and/or NIH/NCI Networks? Are the abilities and availabilities of the investigators
to interact with other SPOREs and with the NIH/NCI in sharing information,
participating in committees, and collaborating on activities of mutual interest
evident and sufficient? (For competing renewal applications, contributions
and outcomes from annual SPORE Workshop and other related SPORE or NIH/NCI
meetings during the term of the award.)

7. Data Management

Are the track records for the overall data management and/or
bioinformatics capabilities of the SPORE as they related to the Cancer Center,
institution, or activities of other NIH/NCI initiatives presented and sufficient
for the requirements of the proposed SPORE?

8. Progress (for Competitive Renewal Applications)

Are the progress and achievements specific to the application
and relevant to translational research since the previous competitive review?
Are the justifications for adding new projects or cores or deleting previous
components appropriate and acceptable?

2.A. Additional Review Criteria

In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and
the priority score:

Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed (see the
Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research:
The adequacy of plans to include subjects from both genders, all racial and
ethnic groups (and subgroups), and children as appropriate for the scientific
goals of the research will be assessed. Plans for the recruitment and retention
of subjects will also be evaluated (see the Research Plan, Section E on Human
Subjects in the PHS Form 398.)

Care and Use of Vertebrate Animals in Research:
If vertebrate animals are to be used in the project, the five items described
under Section F of the PHS Form 398 research grant application instructions
will be assessed.

Biohazards: If materials or procedures are proposed
that are potentially hazardous to research personnel and/or the environment,
determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget
and the requested period of support in relation to the proposed research.
The priority score should not be affected by the evaluation of the budget.

Overall Evaluation and Scoring of Applications:
A single numerical priority score will be assigned to the SPORE application
as a whole after discussing all of the review elements listed above. The score
will be based on the overall quality of the research projects (using the SPORE
definition of translational research as provided in the Executive Summary
and in Part II, Section
I.1. above) and career development and developmental research programs,
the overall effectiveness and adequacy of cores, the overall program organization
and capability including plans or productivity of interactions with other
SPOREs and/or NIH/NCI Networks.

The final overall priority score for the application will
be weighted as follows:

70 percent: scientific merit of the projects and shared
cores, including the likelihood of achieving the proposed translational research
objectives; and

Data Sharing Plan: The reasonableness of the data sharing
plan or the rationale for not sharing research data may be assessed by the
reviewers. However, reviewers will not factor the proposed data sharing plan
into the determination of scientific merit or the priority score. The funding
organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

For SPOREs, this plan should be global in nature to include
research data generated by projects and/or SPORE-supported cores. The plan
should be presented in the Program Description.

The adequacy of the resources sharing plan will be considered
by Program staff of the funding organization when making recommendations about
funding applications. Program staff may negotiate modifications of the data
and resource sharing plans with the awardee before recommending funding of
an application. The final version of the data and resource sharing plans negotiated
by both will become a condition of the award of the grant. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

After the peer review of the application
is completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the eRA Commons.

If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant.
For details, applicants may refer to the NIH Grants Policy Statement Part
II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
e-mail notification from the awarding component to the grantee business official
(designated in item 12 on the Application Face Page). If a grantee is not
e-mail enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization
to begin performance. Any costs incurred before receipt of the NoA are at
the recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See also Section
IV.5. Funding Restrictions.

The NCI is developing a policy that will require Clinical
Terms of Awards for clinical studies and trials when they are a component
of the proposed research. The policy will require that studies be monitored
commensurate with the degree of potential risk to study subjects and the complexity
of the study. The new policy will be posted in the NIH Guide within a few
weeks. All funded applicants will be expected to adhere to the new policy.

Section
VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Inquiries may fall into three areas: scientific/research, peer review, and
financial or grants management issues:

Human Subjects Protection:Federal regulations (45CFR46) require that applications and proposals
involving human subjects must be evaluated with reference to the risks to
the subjects, the adequacy of protection against these risks, the potential
benefits of the research to the subjects and others, and the importance of
the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types of clinical trials,
including physiologic toxicity and dose-finding studies (Phase I); efficacy
studies (Phase II); and efficacy, effectiveness, and comparative trials (Phase
III). Monitoring should be commensurate with risk. The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data sharing
or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions,
on issues related to institutional policies and local institutional review
board (IRB) rules, as well as local, State, and Federal laws and regulations,
including the Privacy Rule. Reviewers will consider the data sharing plan,
but will not factor the plan into the determination of the scientific merit
or the priority score.

Access to Research Data through the Freedom of Information
Act:The Office of Management and Budget (OMB) Circular A-110 has been revised
to provide access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are: (1) first produced in a project
that is supported in whole or in part with Federal funds; and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment.
NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.

Sharing of Model Organisms:NIH is committed to support efforts that encourage sharing of important
research resources including the sharing of model organisms for biomedical
research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time, the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004, receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:It is the policy of the NIH that women and members of minority groups
and their sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects
or the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and responsibilities
of NIH staff and the extramural community. The policy continues to require
for all NIH-defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic
groups, including subgroups if applicable; and b) investigators must report
annual accrual and progress in conducting analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:The NIH maintains a policy that children (i.e., individuals under the
age of 21) must be included in all clinical research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public Access Policy:NIH-funded investigators are requested to submit to the NIH manuscript
submission (NIHMS) system (http://www.nihms.nih.gov/)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting
from: (1) currently funded NIH research projects; or (2) previously supported
NIH research projects if they are accepted for publication on or after May
2, 2005. The NIH Public Access Policy applies to all research grant and career
development award mechanisms, cooperative agreements, contracts, Institutional
and Individual Ruth L. Kirschstein National Research Service Awards, as well
as NIH intramural research studies. The Policy applies to peer-reviewed, original
research publications that have been supported in whole or in part with direct
costs from NIH, but it does not apply to book chapters, editorials, reviews,
or conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.

Standards for Privacy of Individually Identifiable Health
Information:The Department of Health and Human Services (DHHS) issued final modification
to the "Standards for Privacy of Individually Identifiable Health Information,"
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act (HIPAA)
of 1996 that governs the protection of individually identifiable health information,
and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the
Privacy Rule reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information
on the Privacy Rule, including a complete Regulation Text and a set of decision
tools on "Am I a covered entity?" Information on the impact of the
HIPAA Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:All applications and proposals for NIH funding must be self-contained
within specified page limitations. For publications listed in the appendix
and/or Progress report, internet addresses (URLs) must be used for
publicly accessible on-line journal articles. Unless otherwise
specified in this solicitation, Internet addresses (URLs) should
not be used to provide any other information necessary for the
review because reviewers are under no obligation to view the Internet sites.
Furthermore, we caution reviewers that their anonymity may be compromised
when they directly access an Internet site.

Healthy People 2010:The U.S. Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010,"
a PHS-led national activity for setting priority areas. This PA is related
to one or more of the priority areas. Potential applicants may obtain a copy
of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described in the Catalog of Federal Domestic Assistance
at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject
to the terms and conditions, cost principles, and other considerations described
in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide
a smoke-free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the American
people.

Loan Repayment Programs:NIH encourages applications for educational loan repayment from qualified
health professionals who have made a commitment to pursue a research career
involving clinical, pediatric, contraception, infertility, and health disparities
related areas. The LRP is an important component of NIH's efforts to recruit
and retain the next generation of researchers by providing the means for developing
a research career unfettered by the burden of student loan debt. Note that
an NIH grant is not required for eligibility and concurrent career award and
LRP applications are encouraged. The periods of career award and LRP award
may overlap providing the LRP recipient with the required commitment of time
and effort, as LRP awardees must commit at least 50 percent of their time
(at least 20 hours per week based on a 40 hour week) for 2 years to the research.
For further information, please see http://www.lrp.nih.gov/.